NOTE: The policies, guidelines, terms, and conditions
stated in this announcement may differ from those used by the NIH. Where
this Funding Opportunity Announcement (FOA) provides specific written
guidance that may differ from the general guidance provided in the grant application
form, please follow the instructions given in this FOA. Also note that AHRQ may
have different page limits than NIH for the application Research Strategy,
which can be found within each individual FOA (see Section IV below). AHRQ
Grants Policy and Information to applicants regarding Funding Opportunity
Announcement procedures can be found at Funding Opportunity
Announcement Guidance.

This funding opportunity announcement (FOA) solicits Large
Research (R01) grant applications from organizations with large data sets to
conduct research to optimize processes and treatments that provide rapid and
relevant information to the clinical community to best care for patients with
multiple chronic conditions (MCC).

Key Dates

Posted Date

June 14, 2013

Open Date (Earliest Submission Date)

July 28, 2013

Letter of Intent Due Date(s)

July 19, 2013

Application Due Date(s)

August 28, 2013, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date

Expiration Date

August 29, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

This funding opportunity announcement (FOA) solicits large
research (RO1) grant applications from organizations with access to large data
sets to conduct research to optimize processes and treatments that provide
rapid and relevant information to the clinical community to best care for
patients with multiple chronic conditions (MCC).

Background

More than a quarter of all Americans, and two out of three
older Americans, are estimated to have at least two chronic physical or
behavioral health problems. Treatment for people living with these multiple
chronic conditions (MCC) currently accounts for an estimated 66% of the
Nation's health care costs. As the U.S. population ages, the number of patients
with MCC continues to grow. This mounting challenge has become a major public
health issue that is linked to suboptimal health outcomes and rising health
care costs. As part of its ongoing effort to improve care for patients with MCC
through evidence-based research, the Agency for Healthcare Research and Quality
(AHRQ) is soliciting grant applications that utilize existing large data bases
to rapidly conduct research to provide evidence on how to optimize care in MCC
patients.

For the purposes of this FOA, chronic conditions are defined
as conditions that last a year or more and require ongoing medical attention
and/or limit the activities of daily living. Chronic conditions include both
physical conditions such as arthritis, cancer, and HIV infection and mental and
cognitive disorders, such as ongoing depression, substance addiction and
dementia.MCC are concurrent chronic conditions. In other words, multiple
chronic conditions are two or more chronic conditions that affect a person at
the same time. For example, both a person with arthritis and hypertension and
a person with heart disease and depression each have multiple chronic
conditions. See the following website for more information about MCC:

The HHS strategic framework provides a roadmap for
addressing health outcomes for individuals with MCC. HHS and AHRQ’s vision for
MCC patients is: optimum
health and quality of life for individuals with multiple chronic conditions.
To achieve this vision HHS has identified four interdependent areas:

Strengthening the health care and public health systems

Empowering the individual to use self-care management

Equipping care providers with tools, information, and other
interventions

Supporting targeted research about individuals with MCC and
effective interventions

Investigators should consider the above areas when developing
study aims and research questions in response to this FOA.

With this FOA, AHRQ seeks to fund research studies that can
be conducted rapidly (partial results within one year of study being awarded
and expansive study results at the end of year two of study) and will provide
evidence to optimize processes, care, treatments and health of MCC patients.
The goal is to provide scientific evidence and information for use by patients
and the clinical community to best manage care of MCC patients. AHRQ is also
interested in best methods to disseminate study findings to clinicians,
policymakers and patients.

Research
Questions and Specific Aims

Applications must include specific aims and research
questions that seek to improve care and the health of MCC patients. It is
anticipated that the results of these research studies will assist the clinical
community and patients to achieve:

Improved health care outcomes

Better value

Better patient experience

Applications must demonstrate how the research findings will
contribute to progress towards one, two, or all three of these areas.

Examples of potential research questions include, but are
not limited to:

° Is there an optimal ordering of medication and therapy
initiation for people experiencing depression, tobacco addiction, obesity, and
cardiovascular disease?

° How, if at all, should the initiation, frequency, and
ending of routine cancer screening protocols be tailored to best serve people
with multiple chronic conditions?

° Are there clusters of chronic conditions that are
associated with progression to additional chronic conditions, and are there
effective interventions that delay the onset of additional conditions?

° Are certain treatment algorithms associated with increased
efficiency or improved outcomes compared to other options for people with
common clusters of co-existing conditions?

° Are specific treatment approaches associated with
increased or decreased ratings of patient experience of care for people with
multiple chronic conditions compared to other groups?

° Are there interventions that reduce health care
disparities among people with multiple chronic conditions?

Section
II. Award Information

Funding Instrument

Grant

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

AHRQ intends to fund up to four awards for up to a maximum
of $1,600,000, for fiscal year 2014. The number of awards is contingent upon
AHRQ appropriations and the submission of a sufficient number of meritorious
applications.

Award Budget

The total costs (direct and indirect) for a project
awarded under this FOA will not exceed $400,000 for the entire 18 month project
period.

Award Project Period

The project period may not exceed 18 months.

These projects are being funded pursuant to 42 U.S.C. 299a,
which provides that AHRQ shall conduct and support research, support
demonstration projects, and disseminate information on health care and on
systems for the delivery of such care, including activities with respect to the
quality, effectiveness, efficiency, appropriateness, and value of health care
services.

You may submit an application(s) if your
institution/organization is a (an):

Public or non-profit private institution, such as a university,
college, or a faith-based or community-based organization;

Units of local or State government;

Eligible agency of the Federal government.

Indian/Native American Tribal Government (Federally recognized)

Indian/Native American Tribal Government (Other than Federally
recognized);

Indian/Native American Tribally Designated Organization.

AHRQ’s authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research mechanism.
For-profit organizations may participate in projects as members of consortia or
as subcontractors only. Because the purpose of this program is to improve
healthcare in the United States, foreign institutions may participate in
projects as members of consortia or as subcontractors only. Applications
submitted by for-profit organizations or foreign institutions will not be
reviewed. Organizations described in section 501(c) 4 of the Internal
Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform
a substantive role in the conduct of the planned project or program activity
and not merely serve as a conduit of funds to another party or parties. If
consortium/contractual activities represent a significant portion of the
overall project, the applicant must justify why the applicant organization,
rather than the party(s) performing this portion of the overall project, should
be the grantee and what substantive role the applicant organization will play.
Justification can be provided in the Specific Aims or Research Strategy section
of the PHS398 Research Plan Component sections of the SF424 (R&R)
application. There is no budget allocation guideline for determining
substantial involvement; determination of substantial involvement is based on a
review of the primary project activities for which grant support is provided
and the organization(s) that will be performing those activities.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account and should work
with his/her organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, he/she must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for AHRQ support.

Only one PD/PI may be designated on the application.

2. Cost Sharing

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this
FOA, AHRQ welcomes applicant institutions, including any collaborating
institutions, to devote resources to this effort. An indication of
institutional support from the applicant and its collaborators indicates a
greater potential of success and sustainability of the project. Examples of
institutional support would include: donated equipment and space, institutional
funded staff time and effort, or other resource investments. Applicant
institutions should indicate institutional support by outlining the specific
contributions to the project and providing assurances that their organization
and any collaborators are committed to providing these funds and resources to
the project. This information can be included at the end of the budget
justification section of the application, but institutional support dollars are
not to be shown/included in the detailed budget request. Only one PD/PI may be
designated on the application.

3.
Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one
application, provided that each application is scientifically distinct.

AHRQ will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months, except for
submission:

To an RFA of an application that was submitted
previously as an investigator-initiated application but not paid;

Of an investigator-initiated application that was
originally submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows AHRQ staff to estimate the potential review workload
and plan the review.

By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:

Descriptive title of proposed research

Name(s), address(es), and telephone number(s) of the PD/PI

Names of other key personnel

Participating institution(s)

Number and title of this funding opportunity

The letter of intent can be sent electronically, and should
be sent to:

All page limitations described in the SF424 Application
Guide must be followed, with the following exception:

For this specific FOA, the Research Strategy section is limited
to 15 pages.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

Other
Attachments: Provide the following information as a single PDF
file with the name “NAME.pdf.”

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

Budget
Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award
Process. Applicants for funding from AHRQ should ignore application
instructions concerning the Modular Grant Application and Award Process, and
prepare applications using instructions for the Research and Related Budget
Components of the SF 424 (R&R). Applications submitted in the Modular
format will not be reviewed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All application instructions outlined in the SF424 (R&R)
Application Guide that
are not otherwise specified within this Funding Opportunity Announcement must be followed, incorporating "Just-in-Time" information concepts,
and with the following additional requirements:

Introduction (required for a resubmission or revision
application) is limited to 1 page.

Specific Aims is limited to 1 page.

Research Strategy, including tables, graphs, figures,
diagrams, and charts is limited to 15 pages.

The
Research Strategy Section should contain the following sections:

1.
Background/Overview

Applicants are encouraged to provide a very brief background
and overview section demonstrating their understanding of the health and health
care needs of the population of people with multiple chronic conditions they
propose to study and discuss the potential significance of the proposed
project.

2.
Data Set(s)

All research must be conducted on existing large data sets.
Applications must provide a detailed description of the data set or sets to be
utilized. AHRQ has a particular interest in funding research that utilizes
publically available data sets resulting from previous grants supported by AHRQ's
Multiple Chronic Conditions Research Network. More information on these data
sets and how to access them can be obtained at: http://www.ahrq.gov/research/mccrn.htm and http://www.icpsr.umich.edu/icpsrweb/AHRQMCC/.
However, research proposals are not limited to use of these data sets.

An appendix may be used to include letters of support to
demonstrate that the research team has full access to the data that will be
used to conduct the secondary analysis.

3.
Methods

Grant funds may be used to augment or update existing data
sets to answer proposed research questions. However, the application must
provide rationale and a detailed plan and timeline on how the investigators
intend to accomplish an augmentation or modification to existing data sets and
conduct the research and obtain meaningful results within one year of study
being awarded and final results at the end of the study.

If the research plan includes linking data from multiple
data sources or existing data sets, the application must detail how the linking
will be accomplished.

4.
Analysis

The overall strategy, methodology, and analyses must be well-reasoned
and appropriate to accomplish the specific aims and address the research
questions. Potential problems, alternative strategies, and benchmarks for
success must be discussed.

5.
Human Subject Protection and Data Safety and Monitoring

Even though this FOA seeks projects utilizing secondary data
analysis, applications must include an explicit acknowledgement of human
subject protection and data safety risks and an appropriate plan.

6.
Dissemination

The application must include a dissemination strategy which
includes in it a plan that details how the final study results will be
disseminated.

The application must describe a plan for developing a set of
three 1-2 page briefs summarizing project results and implications. The set
should include distinct briefs directed at the following audiences: patients,
clinicians and health care policymakers. The project team should include
expertise in the communication of research results to these audiences. The
final set of three briefs is considered a requirement of the grant, and should
be submitted as part of the final report for this grant and

In addition to these dissemination requirements, AHRQ
encourages scholarly dissemination of study results and implications through
presentation at professional conferences and in scientific journals.

7.
Timeline

Applications must include a timeline that demonstrates how
all research, analysis, and dissemination activities, including development of
an interim findings report and development of at least three final research
summary briefs, will be completed within the maximum 18 month project period.

Budget
Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award
Process. Applicants for funding from AHRQ should ignore application
instructions concerning the Modular Grant Application and Award Process, and
prepare applications using instructions for the Research and Related Budget
Components of the SF 424 (R&R). Applications submitted in the Modular
format will not be reviewed.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide, with the following modification:

An application submitted in response to this FOA may include
in the appendix information that demonstrates that the research team has full
access to all proposed data.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application corrections
that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For efficient grant administration, AHRQ grant
administration procedures will be used and conducted in accordance with the
terms and conditions, cost principles, and other considerations described in
the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own
risk and without AHRQ prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs are necessary to conduct the project and
would be allowable under the grant, if awarded, without AHRQ prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain AHRQ approval before incurring the cost. AHRQ prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the approved
time frame or in any way adversely affect the conduct of the project.

6. Other Submission Requirements and
Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted.

For assistance with your electronic application or for more
information on the electronic submission process, visit Applying
Electronically.

Important
reminders:The PD/P must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF424(R&R)
Application Package. Failure to register in the Commons and to include a valid
PD/PI Commons ID in the credential field will prevent the successful submission
of an electronic application to AHRQ. See Section
III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH, and for responsiveness
by AHRQ. Applications that are incomplete and/or nonresponsive will not be
reviewed.

In order to expedite the review, applicants are requested to
notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and
title, PD/PI name, and title of the application.

AHRQ supports research, evaluations, and demonstration
projects concerning the delivery of health care in inner-city and rural areas
(including frontier areas), and health care for priority populations. Priority
populations include low income groups; minority groups; women; children; the
elderly; and individuals with special health care needs, including individuals
with disabilities and individuals who need chronic care or end-of-life health
care. 42 USC 299(c). Women and members of minority groups are included in all
AHRQ-supported research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate, e.g. because of the lack of connection between the study and the
health of women or particular minorities. Investigators should review the document
entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is
available at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data should describe
briefly the expected schedule for data sharing; the format of the final
dataset; the documentation to be provided; whether or not any analytic tools
also will be provided; whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use); and the mode of data sharing (e.g., under its own
auspices by mailing a disk or posting data on its institutional or personal
website or through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.

The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires
that information that is obtained in the course of AHRQ supported activities
and that identifies individuals or establishments be used only for the purpose
for which it was supplied. Information that is obtained in the course of
AHRQ-supported activities and that identifies an individual may be published or
released only with the consent of the individual who supplied the information
or is described in it. There are civil monetary penalties for violation of the
confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human
Subjects section of the application, applicants must describe procedures for
ensuring the confidentiality of the identifying information to be collected.
The description of the procedures should include a discussion of who will be
permitted access to this information, both raw data and machine readable files,
and how personal identifiers and other identifying or identifiable data will be
restricted and safeguarded. Identifiable patient health information collected
by grantees under this FOA will also be obtained and managed in accordance with
the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containing
confidential data have a level and scope of security that equals or exceeds
that established by the HIPAA Security Rules if applicable (see HIPAA website
in prior paragraph) and that established by the Office of Management and Budget
(OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated
Information Systems. The applicability and intended means of applying these
confidentiality and security standards to subcontractors and vendors, if any,
should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may
copyright, or seek patents for, as appropriate, final and interim products and
materials developed in whole or in part with AHRQ support, including, but not
limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce,
publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities
and to authorize others to do so for any purpose consistent with AHRQ’s
statutory responsibilities. In accordance with its legislative dissemination
mandate, AHRQ purposes may include, subject to statutory confidentiality
protections, making project materials, databases, results, and algorithms
available for verification or replication by other researchers. In addition,
subject to AHRQ budget constraints, final products may be made available to the
health care community and the public by AHRQ or its agents if such distribution
would significantly increase access to a product and thereby produce
substantial or valuable public health benefits. Ordinarily, to accomplish
distribution, AHRQ publicizes research findings but relies on grantees to publish
research results in peer-reviewed journals and to market grant-supported
products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes
to be consulted in advance of publication in order to coordinate announcements
of new AHRQ-supported research results with other AHRQ dissemination
activities. Important legal rights and requirements applicable to AHRQ
grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part
67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html)
which incorporates additional applicable provisions on Rights in Data,
including 45 CFR Part 74 and 37 CFR Part 401.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.:

Section
V. Application Review Information

1. Criteria

The mission of AHRQ is to improve the quality, safety,
efficiency, and effectiveness of health care for all Americans. As part of this
mission, applications submitted to AHRQ to support health services research are
evaluated for scientific and technical merit through the AHRQ peer review
system.

Applications that are complete and responsive to the FOA
will be evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with standard AHRQ peer review procedures that
are described in 42 CFR Part 67, Subpart A. Incomplete and/or
non-responsive applications or applications not following instructions given in
this FOA will not be reviewed.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed and
assigned a priority score

Receive a written critique

Administrative Criteria: Upon receipt, applications will be
evaluated for completeness by the Center for Scientific Review, NIH, and for
responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described
below, will be considered in the review process.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Will the results of the study meaningfully contribute to improved
health and health care for people with MCC? Has the applicant demonstrated how
the results will lead to improved health outcomes, improved health care value,
and/or improved patient experience of care? How will successful completion of
the study aims lead to improved care of MCC patients by clinicians, health
policymakers and patients themselves?

Investigator(s)

Are the PD/PI, collaborators, and other researchers
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the PD/PI and other
researchers? Does the research team have the necessary skills and experience in
conducting research using large data sets on a MCC population? Does the team
contain expertise in developing research summaries that communicate findings
and implications to the public, health care professionals, and health care
policymakers? Is the leadership approach, governance and organization structure
appropriate for the project?

Innovation

Does the project challenge and seek new ways to add
to the understanding and treatment of patients with MCC? Given the limitations
of secondary data analysis, is the project original or innovative? For example:
Does the project challenge current research or seek to shift clinical practice
paradigms; address an innovative hypothesis or critical barrier to progress in
the field; examine an understudied group of MCC patients? Does the project
develop or employ novel concepts, approaches or methodologies, tools, or
technologies for this area?

Approach

Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well-integrated, well-reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative strategies? Are benchmarks for
success presented? Is the data set fully ready to conduct rapid (obtain partial
results within one year of study being awarded and expansive study results at
the end of year two of study) analysis on a MCC population of patients? If
funding is to be used to update or augment data sets, is there a sound plan
(and barriers addressed) to achieve this in a rapid manner? If the project is
in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed?

Environment

Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Degree of Responsiveness

Reviewers will assess how well the application
addresses the purpose and objectives of this FOA. How responsive is the
application to the special eligibility criteria, including the project
requirements, noted in the FOA? [NOTE: Information may be added here]

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to
address the needs of both genders, racial and ethnic minorities (and
subgroups). Reviewers will assess the adequacy of attention to AHRQ
priority populations (see above discussion on Priority Populations in section
IV.6 “Other Submission Requirements”).

Budget and Period of Support

The committee will evaluate whether the proposed
budget is reasonable and whether the requested period of support is appropriate
in relation to the proposed research.

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to
be used to address privacy and security issues in the development and
implementation of the project.

Resubmissions

Not Applicable

Renewals

Not Applicable

Additional Review Considerations

Not Applicable

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group in accordance with AHRQ
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact score.

Will receive a written critique.

Applications will be assigned on the basis of established
AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications
will compete for available funds with all other recommended applications
submitted in response to this FOA. The following will be considered in making
funding decisions:

Scientific and technical merit of the proposed project as
determined by peer review.

Availability of funds.

Responsiveness to goals and objectives of the FOA.

Relevance and fit within AHRQ portfolio priorities, as well as
overall programmatic balance.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, AHRQ will request
"Just-In-Time" information from the applicant. Just-In-Time
information generally consists of information on other support, any additional
information necessary to address administrative and budgetary issues, and
certification of IRB approval of the project's proposed use of human
subjects. For details regarding IRB approval, applicants may refer to the
"AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human
Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization for successful applications. The NoA signed by the AHRQ grants
management officer is the authorizing document and will be sent via email to
the grantee’s business official.

Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NOA are at the
recipient’s risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See also Section IV.5.,
“Funding Restrictions.”

All AHRQ grant and cooperative agreement awards are subject
to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants
Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm),
and the terms and conditions set forth in the Notice of Award.

As necessary, additional Terms and Conditions will be
incorporated into the NoA.

The annual progress reports must include Sections 2.2.6 A
through F as described in the general PHS form 2590 instructions. For details
regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.
If instructions on the AHRQ website are different from the PHS form 2590
instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative
comments on both completed activities and plans for the remainder of that year,
including any changes foreseen in the future. At a minimum, the reports
will include descriptive comments on: progress to date measured against
project aims; methodological changes implemented; key preliminary findings;
significant problems and resolutions; inclusion of priority populations; and
project related publications, presentations, and dissemination activities.
AHRQ does not currently limit the length of the progress report to 2 pages.
AHRQ will provide the due date for submitting annual progress reports. In
addition to the annual progress report, recipients may be required to submit
quarterly progress reports to AHRQ. Detailed instructions on reporting
requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial
Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for
ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).
AHRQ implementation of the FFR retains a financial reporting period that
coincides with the budget period of a particular project. However, the
due date for annual FFRs will be 90 days after the end of the calendar quarter
in which the budget period ends. Note that this is a change in due dates
of annual FFRs and may provide up to 60 additional days to report, depending
upon when the budget period end date falls within a calendar quarter. For
example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013
(90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and
Final Invention Statement are required when an award ends. All final reports
are due within 90 days of the project period end date. For further details
regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Recently issued AHRQ policy notices may affect your
application submission. A full list of policy notices published by AHRQ is
provided in the NIH Guide
for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices..
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement.

Authority and Regulations

This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is
not subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under the authority of
42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74
or 92 and other referenced applicable statutes and regulations. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement. The HHS Grants
Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.